S.I. No. 265/1990:

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) REGULATIONS, 1990.

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) REGULATIONS, 1990.

The Minister for Health in exercise of the powers conferred on him by section 3 of the European Communities Act, 1972 (No. 27 of 1972), hereby makes the following Regulations:--

1. These Regulations may be cited as the European Communities (Cosmetic Products) Regulations, 1990.

2. The European Communities (Cosmetic Products) Regulations, 1984 ( S.I. No. 11 of 1984 ), the European Communities (Cosmetic Products) Regulations, 1986 ( S.I. No. 35 of 1986 ) and the European Communities (Cosmetic Products) (Amendment) Regulations, 1987 ( S.I. No. 240 of 1987 ) are hereby revoked.

3. Article 7 (2) shall cease to have effect on the coming into force of article 7 (3) on 1st day of January, 1992.

4. (1) In these Regulations:--

"the Minister" means the Minister for Health;

"the Principal Directive" means Council Directive 76/768/EEC¹ as amended by Council Directives 79/661/EEC², 82/368/EEC³ 83/574/EEC⁴, 88/667/EEC⁵ and 89/679/EEC⁶ by Commission Directives 82/147/EEC⁷, 83/191/EEC⁸, 83/341/EEC⁹, 8¾96/EEC¹⁰, 84/415/EEC¹¹, 85/391/EEC¹², 86/179/EEC¹³, 86/199/EEC¹⁴, 87/137/EEC¹⁵, 88/233/EEC¹⁶, 89/174/EEC¹⁷ and 90/121/EEC¹⁸;

"sale" includes offering or keeping for sale.

(2) In these Regulations words and phrases shall have the same meaning as in the Principal Directive.

(3) In these Regulations every reference to an article shall, except where otherwise indicated, be construed as a reference to an article contained in these Regulations and likewise any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article.

(4) In these Regulations every reference to an Annex shall be construed as a reference to an Annex contained in the Principal Directive.

5. These Regulations shall not apply to a cosmetic product containing any substance specified in Annex V.

6. A cosmetic product shall not be placed on the market unless it fulfils the requirements of article 2 of the Principal Directive.

7. (1) Subject to the provisions of these Regulations a cosmetic product shall not be placed on the market:--

( a ) if it contains any substance specified in Annex II;

( b ) if it contains any substance specified in Annex III unless the requirements specified for that substance in the said Annex are complied with;

( c ) (i) if it contains any colouring agent not specified in Annex IV; and

(ii) if it contains any colouring agent specified in Annex IV unless the requirements specified for that colouring agent in that Annex are complied with;

( d ) (i) if it contains any preservative not specified in Annex VI; and

(ii) if it contains any preservative specified in Annex VI unless the requirements specified for that preservative in that Annex are complied with;

( e ) (i) if it contains any UV filter not specified in Annex VII; and

(ii) if it contains any UV filter specified in Annex VII unless the requirements specified for that UV filter in that Annex are complied with.

(2) A cosmetic product shall not be placed on the market--

( a ) unless its packaging, container or label bears the information specified in paragraphs (a), (b), (c), (d), and (e) of article 6 (1) of Council Directive 76/768/EEC (as amended by article 9 of Council Directive 82/368/EEC and by articles 1 (4) and 1(5) of Council Directive 83/574/EEC) and the information specified in the said paragraphs (b), (c) and (d) is expressed in the Irish or the English language;

( b ) if the wording, use of names, trade marks, images or other signs, figurative or otherwise, employed in the labelling, presentation for sale or advertising of the product suggests a characteristic which the product in question does not possess.

(3) With effect from the 1st day of January, 1992 a cosmetic product shall not be placed on the market:--

( a ) unless its container and packaging bears, in indelible, easily legible and visible lettering, the information specified in paragraphs (a), (b), (c), (d) and (e) of Article 6 (1) of the Principal Directive and the information specified in the said paragraphs (b), (c) and (d) is expressed in the Irish or the English language;

( b ) if the text, names, trade marks, pictures and figurative and other signs employed in the labelling, presentation for sale and advertising of the product suggests a characteristic which the product in question does not possess.

(4) Without prejudice to article 6, the provisions of sub-article (1) (a) shall not apply to the presence in cosmetic products of traces of any of the substances to which the said sub-article refers where such traces are technically unavoidable in the context of good manufacturing practice and could not reasonably have been removed during or after manufacture.

(5) Subject to sub-articles (6) and (7) a cosmetic product shall not be sold by retail or otherwise supplied to a consumer unless it complies with the provisions of these Regulations relating to the placing of a cosmetic product on the market.

(6) ( a ) The provisions of sub-article (1) shall not apply--

(i) until the 1st day of January, 1991, as respects the requirements of--

--Commission Directive 89/174/EEC insofar as that Directive relates to the substances referred to in paragraphs (2), (4), (5), (7), (8) and (10) of Article 1 thereof;

--Commission Directive 90/121/EEC insofar as that Directive relates to the substances referred to in paragraph (1) of Article 1 thereof;

(ii) until the 1st day of January, 1992, as respects the requirements of Commission Directive 90/121/EEC insofar as that Directive relates to the substances referred to in paragraphs (3), (5), (6) and (8) of Article 1 thereof.

( b ) The provisions of sub-article (1) (c) shall not apply to cosmetic products containing colouring agents intended solely to colour hair.

( c ) The provisions of sub-article (5) shall not apply--

(i) until the 31st day of December, 1990, as respects the requirements of Commission Directive 87/137/EEC and in the case of Commission Directive 89/174/EEC insofar as that Directive relates to the substances referred to in paragraph (1) of Article 1 thereof;

(ii) until 31st day of December, 1991, as respects the requirements of--

--Commission Directive 88/233/EEC insofar as that Directive relates to the substances referred to in paragraphs (2), (3), (6) and (7) of Article 1 thereof;

--Commission Directive 90/121/EEC insofar as that Directive relates to the substances referred to in paragraph 1 of Article 1 thereof;

(iii) until the 31st day of December, 1992, as respects the requirements of Commission Directive 89/174/EEC insofar as that Directive relates to the substances referred to in paragraphs (2), (4), (5), (7), (8) and (10) of Article 1 thereof;

(iv) until the 31st day of December, 1993, as respects the requirements of Commission Directive 90/121/EEC insofar as that Directive relates to the substances referred to in paragraphs (3), (5), (6) and (8) of Article 1 thereof.

(7) Notwithstanding the provision of sub-article (5) and without prejudice to sub-article (6), a cosmetic product lawfully placed on the market and in compliance with the labelling provisions in operation prior to the coming into force of sub-article (3) may, until 31st day of December, 1993, be sold by retail or otherwise supplied to a consumer.

8. (1) Notwithstanding the provisions of article 7 (1) and subject to sub-articles (2), (3) and (4) the Minister may grant, to any person who applies in the form and manner required by him, an authorisation to place a cosmetic product on the market containing a substance not otherwise permitted by virtue of these Regulations.

(2) An authorisation granted under sub-article (1) shall be limited in duration to a maximum period of three years and shall be subject to such conditions as the Minister may specify and, in particular, to conditions:--

( a ) specifying the cosmetic product or class of cosmetic product in which the said substance may be used, and

( b ) specifying a distinctive indication which the said cosmetic product or class of cosmetic product must bear.

(3) The period specified in an authorisation for the purpose of sub-article (2) shall be extended until a decision is made following a request pursuant to paragraph 3 of article 8 (a) of the Principal Directive, for the inclusion of the substance to which the authorisation relates in a list of permitted substances.

(4) There shall be paid to the Minister a fee of £525 in respect of each application for an authorisation under sub-article (1).

9. A person who contravenes any provision of article 6 or 7, or any condition attached to an authorisation granted under article 8, shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000 and, in the case of a continuing offence, to a further fine not exceeding £100 for each day on which the offence is continued.

10. (1) Subject to sub-articles (2) and (3), these Regulations may be enforced by officers of the Minister and by health boards and their officers.

(2) The provisions of article 7 (2) (a) (insofar as they relate to compliance with article 6 (1) (b) of Council Directive 76/768/EEC) and of article 7 (2) (b) shall be enforced by officers of the Minister for Industry and Commerce.

(3) The provisions of article 7 (3) (a) (insofar as they relate to compliance with article 6 (1) (b) of the Principal Directive) and of article 7 (3) (b) shall be enforced by officers of the Minister for Industry and Commerce.

11. For the purpose of ascertaining whether or not there is or has been a contravention of article 6 or 7, an officer specified in article 10 (with, in the case of an officer of the Minister, a written authorisation of the Minister, in the case of an officer of the Minister for Industry and Commerce, a written authorisation of the Minister for Industry and Commerce and in the case of an officer of a health board, a written authorisation of the board) may, at all reasonable times--

(1) enter any premises (not being a premises used only as a private dwelling) where cosmetic products are manufactured, stored, sold or offered or kept for sale; and

(2) inspect and take (without payment) samples of any cosmetic product which is manufactured, stored, sold or offered or kept for sale at such premises, for test, examination or analysis.

12. The official testing of cosmetic products by, or under the direction of any of the persons specified in article 13 (1) shall be carried out in accordance with the methods described in Commission Directives 80/1335/EEC¹⁹, 82/434/EEC²⁰, 83/514/EEC²¹, 85/490/EEC²², 87/143/EEC²³ and 90/207/EEC²⁴ insofar as such methods are applicable.

13. (1) In any proceedings for an offence under article 9 a certificate signed by--

( a ) the State Chemist, or

( b ) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875, or

( c ) a chemist or analyst appointed by the Minister for that purpose

stating the results of any test, examination or analysis of a sample shall, with regard to that sample, be evidence for all purposes of such result.

(2) The certificate referred to in sub-article (1) shall be in the form set out in the Schedule to these Regulations.

SCHEDULE.

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) REGULATIONS, 1990.

(S.I. No.  of 1990)

CERTIFICATE STATING RESULTS OF TESTS, EXAMINATION OR ANALYSIS

This Certificate is issued by me, the undersigned, for the purpose of article 13 of the European Communities (Cosmetic Products) Regulations, 1990 being⁽¹⁾____________________________________________________________________

I hereby certify that I received on the _____ day of _________________ 19 ____ from⁽²⁾ _______________________________ of _________________________________________ a sample of ⁽³⁾ _____________________________ for test, examination or analysis; which was undamaged, duly sealed and marked ⁽⁴⁾_______________________

I further certify that the said sample has been tested, examined or analysed by me or under my direction and that the results are as follows:--⁽⁵⁾

Signature _______________________________ date _______________________

Address ________________________________

________________________________

⁽¹⁾Here insert official title of analyst.

⁽²⁾Here insert the name of the sampling officer who submitted the sample for analysis.

⁽³⁾Here insert the name or description of the product.

⁽⁴⁾Here insert the distinguishing mark on the sample and the date of sampling shown thereon.

⁽⁵⁾Here insert the relevant results as appropriate.

GIVEN under the Official Seal of the Minister for Health this 15th day of November, 1990.

RORY O'HANLON,

Minister for Health.

OFFICIAL JOURNAL REFERENCES.

¹Official Journal of the European Communities, No. L262, 27/9/76 (pages 169-200).

²Official Journal of the European Communities, No. L192, 31/7/79 (page 35).

³Official Journal of the European Communities, No. L167, 15/6/82 (pages 1-32).

⁴Official Journal of the European Communities, No. L332, 28/11/83 (pages 38-42).

⁵Official Journal of the European Communities, No. L382, 31/12/88 (pages 46-48).

⁶Official Journal of the European Communities, No. L398, 30/12/89 (page 25).

⁷Official Journal of the European Communities, No. L63, 6/3/82 (page 26).

⁸Official Journal of the European Communities, No. L109, 26/4/83 (pages 25-27).

⁹Official Journal of the European Communities, No. L188, 13/7/83 (page 15).

¹⁰Official Journal of the European Communities, No. L275, 8/10/83 (pages 20-21).

¹¹Official Journal of the European Communities, No. L228, 25/8/84 (pages 31-33).

¹²Official Journal of the European Communities, No. L224, 22/8/85 (pages 40-41).

¹³Official Journal of the European Communities, No. L130, 24/5/86 (pages 40-48).

¹⁴Official Journal of the European Communities, No. L149, 3/6/86 (pages 38-45).

¹⁵Official Journal of the European Communities, No. L56, 26/2/87 (pages 20-21).

¹⁶Official Journal of the European Communities, No. L105, 26/4/88 (pages 11-14) and corrigendum published on 24/6/88 in No. L157 (page 38).

¹⁷Official Journal of the European Communities, No. L64, 8/3/89 (pages 10-13) and corrigendum published on 13/7/89 in No. L199 (page 23).

¹⁸Official Journal of the European Communities, No. L71, 17/3/90 (pages 40-42).

¹⁹Official Journal of the European Communities, No. L383, 31/12/80 (pages 27-46).

²⁰Official Journal of the European Communities, No. L185, 30/6/82 (pages 1-28).

²¹Official Journal of the European Communities, No. L291, 24/10/83 (pages 9-46).

²²Official Journal of the European Communities, No. L295, 7/11/85 (pages 30-45).

²³Official Journal of the European Communities, No. L57, 27/2/87 (page 56).

²⁴Official Journal of the European Communities, No. L108, 28/4/90 (pages 92-101).

EXPLANATORY NOTE.

The purpose of the Regulations is to up-date the law in relation to the marketing and sale of cosmetic products by giving effect to the most recent EC Directives on cosmetic products (viz Council Directives 88/667/EEC and 89/679/EEC and Commission Directives 88/233/EEC, 89/174/EEC, 90/121/EEC and 90/207/EEC) and to consolidate in one set of Regulations the law in relation to cosmetic products.

The effect of the Regulations is to prohibit the placing on the market of cosmetic products which, under normal conditions of use, are liable to cause damage to human health. The presence in cosmetic products of certain listed substances is either prohibited absolutely or permitted subject to certain restrictions. Positive lists of colouring agents, anti-microbial preservatives and ultraviolet sun-screen filters are established which, subject to compliance with any prescribed restrictions are permitted to be used.

Certain requirements in regard to labelling are also laid down and the use of words, names, trade marks, images or other signs either in the labelling, presentation for sale or advertising of cosmetic products is prohibited where such suggests a characteristic which the product in question does not possess. Some changes are provided for which come into effect on 1st January, 1992. As from that date this information must be on the container and other packaging and must be easily legible.